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binx io CT/NG Assay and binx io CT/NG System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200533
510(k) Type
Traditional
Applicant
binx health Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/27/2020
Days to Decision
56 days
Submission Type
Summary

binx io CT/NG Assay and binx io CT/NG System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200533
510(k) Type
Traditional
Applicant
binx health Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/27/2020
Days to Decision
56 days
Submission Type
Summary